[Research progress on the safety of paclitaxel drug-loaded devices].

Abstract

In endovascular treatment of peripheral arterial disease, paclitaxel-coated device (PCD) have been widely used to reduce vascular restenosis, yet their safety remains controversial. Some scholars have suggested that PCD might increase long-term mortality, sparking widespread concern and debate. In recent years, a number of studies have provided support for the safety of PCD, believing that PCD have advantages in terms of re-intervention, patency rate, and reduction of amputation risk, and do not increase the risk of death. There is no direct relationship between the paclitaxel dose and mortality. Overall, the safety controversy primarily stems from methodological limitations in early studies. The latest research has provided safety evidence for their clinical application. However, further investigations are required to define the boundary conditions for their long-term safety, elucidate variations in responses across different patient populations, and clarify paclitaxel's mechanisms of action in vivo. Such efforts will facilitate optimal balancing of therapeutic efficacy and safety in clinical applications.